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Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy

18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy

Irinotecan is a camptothecin analog which exerts its cytotoxic effects by forming a covalent
complex with topoisomerase I and DNA, resulting in inhibition of DNA re-ligation,
accumulation of DNA double strand breaks and apoptotic cell death (1). Irinotecan is FDA
approved for use in the front-line and second-line treatment of colorectal cancer. It has
also demonstrated activity in a variety of other non-hematologic tumors. The recently
updated ASCO antiemetic guidelines characterize irinotecan as having moderate emetic risk.
(2). However, the emetogenic potential of this agent has been poorly characterized and there
are no published prospective trials with emesis as a primary-end point. In addition there is
a complete paucity of information on the potential of irinotecan to induce emesis beyond the
first day after chemotherapy, so-called delayed emesis. Best characterized following
cisplatin, delayed emesis is also associated with a number of other chemotherapy agents that
similar to irinotecan appear to be moderately emetogenic such as carboplatin,
cyclophosphamide and doxorubicin. Antiemetic prophylaxis for delayed emesis following
irinotecan is not routinely prescribed at the present time. Prospectively obtained
information on the potential of irinotecan to cause delayed emesis would be helpful in
guiding appropriate antiemetic practice.

Inclusion Criteria:

- Patients with colorectal cancer receiving irinotecan in combination with infusional
fluorouracil and leucovorin (FOLFRI) with or without bevacizumab or irinotecan in
combination with cetuximab

- All patients will receive the following standard antiemetic regimen prior to

- Dexamethasone 8 mg PO/IV

- An approved dose of a 5HT3 receptor antagonist. Ondansetron 8mg IV or 24mg PO
Dolasetron 100mg IV/PO Granisetron 1 mg IV or 2mg PO Use of palonosetron will be
excluded on this trial No routine prophylaxis for delayed emesis will be given.
Patients will be instructed in the use of rescue antiemetics if needed.

- Minimum age of 18 years.

- Premenopausal patients must demonstrate a negative serum or urine pregnancy test
prior to receiving chemotherapy.

- ECOG performance status of 0-2 (Appendix A)

- Execution of written informed consent

Exclusion Criteria:

- Patients with history of moderate-severe nausea or any vomiting with prior
chemotherapy including irinotecan based chemotherapy.

- Concomitant use of any drug with potential antiemetic efficacy (Appendix B) 24 hours
before chemotherapy and during the 120 hour study period. Chronic use (more than 2
weeks) of benzodiazepines is allowed.

- Vomiting, retching or nausea (NCI > 1) in the 24 hours preceding chemotherapy

- Palliative surgery < 2 weeks from study entry

- Concurrent radiotherapy

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

frequency of delayed emesis (vomiting/retching)

Outcome Time Frame:

days 2 - 5

Safety Issue:


Principal Investigator

Paul J Hesketh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Steward St. Elizabeth's Medical Center of Boston, Inc.


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

December 2009

Related Keywords:

  • Colorectal Cancer
  • nausea vomiting colorectal cancer
  • Colorectal Neoplasms
  • Nausea
  • Vomiting



Caritas St. Elizabeth Medical CenterBrighton, Massachusetts  02135